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51-410: The GHIT Fund is the first public-private partnership fund to involve a national government, a UN agency, a consortium of pharmaceutical and diagnostics companies, and international philanthropic foundations. The public-private partnership model, the inclusion of a whole pharmaceutical sector and the structure of individual research projects across sectors and national boundaries are all aimed at reducing

102-592: A "merger of equals," forming Astellas Pharma on 1 April 2005. At least some of its older products continue to be distributed under the original brand, ostensibly due to high brand-name recognition. Astellas had a collaboration agreement with CoMentis from 2008 to 2014 focused on development of beta-secretase inhibitor therapeutics for Alzheimer's disease . In 2009, the company's tacrolimus-containing products Prograf and Advagraf showed they were prone to dosing errors within Europe, leading to serious adverse reactions among

153-469: A G7 Summit communique a US$ 130 million contribution to the GHIT Fund/UNDP. On June 1, 2017 GHIT announced it had secured commitments of over US$ 200 million for its next phase of work, allowing it to move the most advanced tools out of the lab, and into the hands of those who need them most. The new commitment for GHIT’s second phase is double the initial US$ 100 million investment GHIT received when it

204-525: A Japanese American mother and was the a grandson of one of the first people of Japanese descent to be fully trained as an American physician. In 1960, he moved to the United States where he completed his education. After attending Phillips Academy for his high school education, he graduated from Stanford University with a BA in history and obtained his M.D. from New York University School of Medicine . He completed his internal medicine training at

255-614: A board member of Takeda Pharmaceuticals , and served as the chief medical and scientific officer of the company. Before joining Takeda, Yamada was the president of the global health program at the Bill & Melinda Gates Foundation . In this capacity he oversaw grants totaling over $ 9 billion in programs directed at applying technologies to address major health challenges of the developing world including TB, HIV, malaria and other infectious diseases, malnutrition and maternal and child health. Yamada served as Chairman of Research and Development and

306-690: A co-funding strategy in place, though GHIT strongly encourages co-funding for the entire portfolio. In December 2017 GHIT announced a partnership with the European & Developing Countries Clinical Trials Partnership (EDCTP) to support product development research, specifically by co-funding the PZQ4PSAC phase III clinical study, which is sponsored by Merck KGaA and conducted by the Pediatric Praziquantel Consortium. This study provides clinical data and support for registration of

357-464: A further $ 176.5 million upon the achievement of predetermined milestones. In May 2023, the business announced it would acquire Iveric Bio for $ 5.9 billion. In November, Astellas announced it would acquire Propella Therapeutics, Inc. and its lead androgen biosynthesis inhibitor abiraterone decanoate (PRL-02) used to treat prostate cancer. The following is an illustration of the company's major mergers and acquisitions and historical predecessors (this

408-490: A monoclonal antibody targeting Claudin 18.2 (CLDN18.2), for the treatment of HER2-negative gastric or gastroesophageal junction adenocarcinoma . Zolbetuximab is the first treatment of its kind in the region, and a decision on its approval is expected by 12 January 2024, based on the Phase III SPOTLIGHT and GLOW clinical trial results. In 2007, the company narrowed UK distribution of Advagraf and Prograf to

459-539: A new praziquantel (PZQ) tablet formulation to treat schistosomiasis in preschool-aged children. The GHIT Fund's full investment portfolio, with detailed background on specific development partnerships, is on its website. In 2013, the original partners to the Fund initially committed over US$ 100 million over 5 years. Half came from the two Japanese ministries, and the other half came from Japanese pharma Astellas , Eisai , Daiichi Sankyo , Shionogi , and Takeda together with

510-509: A number of patients, due to deficits in packaging and labeling, deficits corrected after a warning from the UK MHRA . On June 9, 2010, Astellas acquired OSI Pharmaceuticals for $ 4.0 billion. In December 2014, Astellas expanded its 18-month-old collaboration with Cytokinetics, focusing on the R&;D and commercialization of skeletal muscle activators. The companies announced they will advance

561-726: A sole distributor, UniChem, in reaction to pharmacist complaints about drug availability from wholesale sources. This narrow distribution was revised to three firms in 2010, covering all of its products in the UK: AAH, Alliance Healthcare , and Phoenix Healthcare Distribution. The company's headquarters are in Tokyo , with research centers in Tsukuba and Osaka . Clinical development is centered in Northbrook, Illinois , La Jolla, California , and Leiden , Netherlands. Combined revenues of

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612-641: A total of eight drugs". In December 2018, the Prescription Medicines Code of Practice Authority (PMCPA) published their findings following an allegation that Astellas had "inappropriately awarded research funding" to a senior clinician at a British hospital, directly resulting in the hospital adopting a protocol which was subsequently abandoned less than three years later "because of poor outcomes". This report also reprimanded Astellas for failing to provide sufficient and timely information to investigators. In April 2019, Astellas agreed to pay

663-431: A total €800 million, strengthening its late-stage pipeline with Ogeda's drug candidate, fezolinetant . In November 2017, the company announced that it exercised an option to purchase Cambridge, Massachusetts-based Mitobridge, which is developing treatments for Duchenne muscular dystrophy and age-related diseases . In August 2018, Astellas announced it would acquire Quethera Limited for $ 109 million. In December 2018,

714-612: Is a major proponent. The GHIT Fund invests across four research platforms (Target Research, Screening, Hit-to-Lead, and Product Development) in R&D partnerships among Japanese pharmaceutical companies and research institutes and universities with non-Japanese research institutes and universities. This gives researchers around the world access to Japanese expertise and investment. The Fund deliberately refers to grants as "investments" and grantees as "development partners." Investments go to R&D projects that aim to develop new health technologies for infectious diseases. Diseases targeted by

765-661: Is a member of the Mitsubishi UFJ Financial Group (MUFJ) keiretsu . Fujisawa Shoten was started in 1894 by Tomokichi Fujisawa in Osaka , and was renamed Fujisawa Pharmaceutical Co. in 1943. Yamanouchi Yakuhin Shokai was started in 1923 by Kenji Yamanouchi in Osaka. The company was renamed Yamanouchi Pharmaceutical Co. in 1940 and moved to Tokyo in 1942. Both companies started their overseas expansion at about

816-610: Is a pediatric formulation of praziquantel, a drug widely used to schistosomiasis, a disease caused by parasitic flatworms. The idea of a Japanese nonprofit focused on global health R&D was conceived during a conversation between Tachi Yamada and a former executive at Eisai Co. Ltd., BT Slingsby – the fund's first CEO and founder of GHIT. A launch committee was set up in 2012 among the Government of Japan's Ministry of Foreign Affairs and Ministry of Health, Labour and Welfare, Astellas , Daiichi Sankyo , Eisai , Shionogi , Takeda ,

867-610: Is governed and managed by an international Board of Directors. The Board is responsible for establishing the organization’s by-laws, providing fiduciary oversight, approving investment recommendations from the Selection Committee, and assessing the Fund’s overall performance. Dr. Kiyoshi Kurokawa is Chair of the Board and Dr. BT Slingsby is the founding CEO and Executive Director. GHIT’s Selection Committee operates separately from

918-682: Is not a comprehensive list): In June 2016, the Association of the British Pharmaceutical Industry (ABPI) gave Astellas a year-long suspension, after complaints it had "purposely misled the PMCPA." In particular, Astellas had not fully disclosed the nature of a meeting which had purported to be a "genuine advisory board". In May 2017, the ABPI extended the suspension by a further 12 months, based on findings that Astellas

969-524: The Academy of Medical Sciences (UK) and the American Academy of Arts and Sciences . Among his many other activities he was a member of the board of directors of public corporations across four continents and was a member of the board of Agilent Technologies and chaired the boards of Phathom Pharmaceuticals and Passage Bio, two companies for which he was a founder. He also served as a member of

1020-1191: The American Physiological Society , the Julius Friedenwald Medal from the American Gastroenterological Association , the Distinguished Faculty Achievement Award from the University of Michigan , the Distinguished Medical Scientist Award from the Medical College of Virginia and the August M. Watanabe Prize in Translational Research from the Indiana University School of Medicine . Yamada was conferred

1071-484: The Bill & Melinda Gates Foundation . By 2015, funding for GHIT increased to US$ 140 million with the addition of new partners and sponsors. New partners Chugai, Sysmex, and the Wellcome Trust had joined. The Wellcome Trust alone brought in an additional approximately US$ 4.6 million through January 2017. Three additional companies ( All Nippon Airways , law firm Morrison Foerster LLP, and Yahoo!Japan ) joined

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1122-501: The Bill & Melinda Gates Foundation . This committee worked collectively to design the organization based on the idea that new investment and innovation are needed to address some of the world’s most neglected diseases and that Japan – a leader in health technologies innovation – could be doing more in the global fight against infectious diseases. The launch committee also designed the unique governance model to minimize potential conflicts of interest in investment decision-making. In 2013,

1173-981: The Most Excellent Order of the British Empire . He was a fellow of the Imperial College London , a Master of the American College of Physicians and a Fellow of the Royal College of Physicians ; and gave the last centenary lecture at Imperial College London in March 2008, which was chaired by Sir Richard Sykes . He was also the recipient of numerous awards, including the Smith Kline & French Award in Gastrointestinal Physiology from

1224-481: The United States Department of Justice $ 100 million to resolve allegations that it had conspired to offer kickbacks via Medicare copay foundations. Astellas' franchise areas are oncology , urology , immunology ( transplantation ), cardiology , and infectious disease . Priority areas for R&D are infectious diseases , diabetes , gastrointestinal diseases , oncology , and diseases of

1275-422: The central nervous system . Recently noted, Astellas Venture Management has funded Oncorus, which recently raised $ 79.5 million in a series B financing round to move two oncolytic viruses through development. Some of the main products produced by Astellas include: The US Food and Drug Administration (FDA) has granted priority review to Astellas Pharma's biologics licence application (BLA) for Zolbetuximab ,

1326-426: The 24 novel screening programs have advanced into next stage of development; six candidates have successfully achieved first-in-human trials, and two projects have achieved Proof of Concept (Phase II). Approximately 42% of GHIT’s investments have been allocated to projects related to malaria, 13% to tuberculosis, and the rest to NTDs. With regard to product type, 71% of investments have been in drugs, 24% in vaccines, and

1377-466: The Board of Directors and advocates for GHIT’s mission. Council members are never involved in operational and/or funding decisions. Tachi Yamada Tadataka " Tachi " Yamada KBE (山田忠孝 Yamada Tadataka or "ターチ Tachi"; 5 June 1945 – 4 August 2021) was a Japanese-born American physician and gastroenterologist. He was a venture partner of Frazier Healthcare Partners . Born in Tokyo, Yamada had

1428-524: The Board of Directors. This is to ensure objectivity, transparency, and accountability of the investment-making and evaluation process. The Selection Committee consists of renowned experts in product development for infectious diseases from across the globe and evaluates proposals, and development partner reports, and recommends the provision of GHIT’s investments to the Board. To add another layer of accountability and scientific rigour, External Reviewers consisting of more than 100 global health experts from around

1479-409: The Fund as a long-term investment into the future, rather than charity. They see the Fund as a necessary catalyst for having allowed them to pursue this line of research. By 2022 (the end of the Fund’s second five-year phase), GHIT aims to bring two of its projects to a stage where a request for regulatory approval is filed. One of the products in the pipeline and among the closest to hitting the market

1530-617: The Fund as sponsors in the summer of 2015 to provide in-kind services in support of the Fund’s work. Yahoo!Japan has co-launched a special joint website with the Fund: “Save millions of lives from infectious diseases” Archived 9 October 2015 at the Wayback Machine . A replenishment for the GHIT's second five-year phase was initiated in May 2016 as the Government of Japan announced as part of

1581-748: The Fund include HIV , malaria , tuberculosis , and neglected tropical diseases . The Fund also works with established product development partnerships such as the Global Alliance for Tuberculosis Drug Development ( TB Alliance ), Medicines for Malaria Venture , and Geneva-based Drugs for Neglected Diseases initiative to screen the large number of potential drug candidates residing in private and public sector chemical compound libraries in Japan. The GHIT Fund utilizes private-sector standards for product development (e.g., using typical milestones and stage gates for timeline management). GHIT invests heavily in

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1632-488: The GHIT Fund formally launched with an initial commitment of over US$ 100 million. Original Board members included Kiyoshi Kurokawa, Peter Piot , Ann Veneman , and Ko-Yung Tung. In their own words, the vision of the founders of the GHIT Fund is “one in which the crushing burden of infectious disease no longer prevents billions of people in the developing world from seeking the level of prosperity and longevity now common in

1683-864: The Medical College of Virginia, and then became an investigator in the United States Army Medical Research Institute of Infectious Diseases holding the rank of major, U.S. Army Medical Corps. Subsequently, he trained in gastroenterology at the UCLA School of Medicine and assumed his first faculty position there. He later moved to the University of Michigan where he headed the Gastroenterology Division and ultimately became chairman, Department of Internal Medicine and Physician-in-Chief of

1734-791: The President's Council of Advisors on Science and Technology, vice-chair of the Council of the National Academy of Medicine (US), president of the Association of American Physicians and president of the American Gastroenterological Association . He served as a member of the board of the University of Michigan Health System and as chairman of the board of the Clinton Health Access Initiative . Yamada received an honorary appointment as Knight Commander of

1785-441: The R&D risk to any one entity and ensuring that findings are open to all. Another key opportunity the GHIT Fund has created has been to help open the doors of Japan’s public and private drug compound libraries to product development partnerships, which makes possible the screening of tens of thousands of drug candidates for potential new treatments. The participating companies view their investments into neglected diseases through

1836-443: The University of Michigan Medical Center before joining GlaxoSmithKline. A scientist and scholar in gastroenterology, Yamada was the author of more than 150 original manuscripts on the subject and was the editor of The Textbook of Gastroenterology for its first five editions. The studies undertaken by Yamada and his collaborators led to basic discoveries in the post-translational processing and biological activation of peptide hormones,

1887-840: The company announced it would acquire Potenza Therapeutics, Inc. In December 2019, Astellas Pharma announced it would buy Audentes Therapeutics Inc for approximately $ 3 billion in cash as well as acquiring Xyphos Biosciences, Inc later in the same month. Audentes will operate as a wholly owned subsidiary within Astellas, and will serve as the Center of Excellence for the newly created Genetic Regulation Primary Focus, providing leadership for AAV pipeline advancement through commercialization, manufacturing expansion, and next-generation research initiatives. The acquisition includes Astellas gaining Xyphos’ Advanced Cellular Control through Engineered Ligands (ACCEL) technology platform. On February 5, 2020,

1938-410: The company announced management changes effective from April 1, 2020. Astellas Pharma's Smyraf (ingredient: peficitinib ) obtained regulatory approval for the treatment of rheumatoid arthritis , the third oral Janus kinase (JAK) inhibitor to receive approval. In October 2020, Astellas announced it would acquire iota Biosciences, Inc. for $ 127.5 million, with shareholders eligible to receive up to

1989-466: The development of CK-2127107 (a fast skeletal troponin activator) into Phase II clinical trials for the treatment of spinal muscular atrophy and possibly other neuromuscular conditions. The collaboration was expected to generate more than $ 600 million for Cytokinetics, as well as $ 75 million in milestone payments. In November 2015, the company announced its move to acquire Ocata Therapeutics (formerly Advanced Cell Technology) for $ 379 million. The deal

2040-434: The industrialized world”. The Fund’s stated mission is “to facilitate international partnerships that enable Japanese technology, innovations, and insights to play a more direct role in reducing disparities in health between the rich and the poor of the world.” In keeping with this vision and mission, global health R&D is considered to be indispensable to the realization of universal health coverage (UHC), for which Japan

2091-402: The management and evaluation of projects and is rigorous about achievement milestones, swiftly terminating non-performers. But while GHIT has a “private-sector” orientation to the management of investments, there is no expectation of financial return. Co-funding of projects is another key investment management tool. Candidate products that have achieved proof-of-concept (POC) are required to have

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2142-417: The overhead expenses of the Fund. GHIT’s Phase 2.0 strategic plan anticipates that by the end of FY2022 two products in its pipeline will be approved by a stringent regulatory authority. As of December 2017 GHIT has invested over of US$ 115 million across four research platforms into more than 60 global product development partnerships that leverage Japanese innovation and capacities in pharmaceuticals. Seven of

2193-426: The rest in diagnostics. Products resulting from research must be appropriate, effective, affordable, and accessible for the poorest of the poor. In fact, all grant investment proposals must prioritize open innovation and guarantee that products will be developed on a "no gain, no loss" basis, meaning in the poorest countries drugs will be licensed without royalties, while in others, they will be licensed at cost. GHIT

2244-587: The same time, opening offices in Taiwan in 1962 and 1963, respectively, and in the United States and Europe from 1977 onwards. Fujisawa acquired Lyphomed in 1990 and thereafter established its US R&D center in Deerfield, Illinois . Yamanouchi's R&D center in Leiderdorp was established with the acquisition of the pharmaceutical division of Royal Gist Brocades in 1991. Fujisawa and Yamanouchi combined in

2295-411: The structure and function of receptors for hormones regulating gastric acid secretion, and the regulation of genes involved in the acid secretory process. He was awarded honorary doctorates by the University of Michigan, University of East Anglia, the University of Warwick, Washington College, and Loyola University of Chicago. Prior to Frazier Healthcare Partners, Yamada was executive vice-president and

2346-796: The title Honorary Citizen of Singapore in 2016; and the Order of the Rising Sun , Gold and Silver Stars, from the Japanese Government. Astellas Astellas Pharma Inc. ( アステラス製薬株式会社 , Asuterasu Seiyaku Kabushiki-gaisha ) is a Japanese multinational pharmaceutical company , formed on 1 April 2005 from the merger of Yamanouchi Pharmaceutical Co., Ltd. ( 山之内製薬株式会社 , Yamanouchi Seiyaku Kabushiki-gaisha ) and Fujisawa Pharmaceutical Co., Ltd. ( 藤沢薬品工業株式会社 , Fujisawa Yakuhin Kōgyō Kabushiki-gaisha ) . Astellas

2397-514: The world provide independent reviews of R&D proposals to the GHIT Fund and its Selection Committee. To further preemptively counter any potential conflicts of interest, all Selection Committee members, including academicians, must declare that they have no relation to proposal applicants or abstain from any decision-making process in the instance when they may. GHIT’s Council, which includes participating pharmaceutical companies and government and international funding entities, provides oversight for

2448-590: Was a member of the board of directors at GlaxoSmithKline before joining the foundation. In 2007, Yamada was asked by the US Senate Committee on Finance to provide information concerning his response to critics of GSK's anditabetes drug, Avandia . In recognition of his contributions to medicine and science he was elected to membership in the National Academy of Medicine (US) and the National Academy of Medicine (Mexico) and to Fellowship in

2499-561: Was completed in February 2016. Later in November 2015 the company announced it would sell its dermatology business to LEO Pharma for $ 725 million. In October 2016 Astellas announced it would acquire Ganymed Pharmaceuticals for $ 1.4 billion In March 2017, the company sold 16 of its drugs to LTL Pharma for ¥20.1 billion ($ 133 million). In April 2017, the company announced it would acquire Belgium-based drug discovery firm Ogeda for up to

2550-711: Was created in 2013. Also in June 2016 ten companies joined GHIT, including a full funding partnership with FUJIFILM Corporation, an associate partnership with Otsuka Pharmaceutical , affiliate partnerships with GlaxoSmithKline , Johnson & Johnson , Kyowa Hakko Kirin , Merck , Mitsubishi Tanabe Pharma Corporation , Nipro Corporation , Sumitomo Dainippon Pharma , and sponsorship from Salesforce.com . There are currently three levels of pharmaceutical and diagnostic partners - Full partners, Associate partners, and Affiliate partners. Additionally, non-biopharmaceutical companies engage as Sponsors, contributing in-kind services to reduce

2601-423: Was not adequately overseeing and training nurses, and that it had failed to provide complete prescribing information for several medicines. In June 2017, Astellas was reprimanded for "producing a large number of promotional materials, which had been used for a number of years, that did not include the required prescribing information related to some serious or common adverse reactions, warnings, and precautions, for

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